| Device Classification Name |
accessory, assisted reproduction |
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|---|---|---|---|---|
| 510(k) Number | K991408 | |||
| Device Name | FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR | |||
| Applicant |
|
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| Applicant Contact | richard l miller | |||
| Correspondent |
|
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| Correspodent Contact | richard l miller | |||
| Regulation Number | 884.6120 | |||
| Classification Product Code |
|
|||
| Date Received | 04/22/1999 | |||
| Decision Date | 07/19/1999 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Obstetrics/Gynecology |
|||
| 510k Review Panel |
Obstetrics/Gynecology |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |